Monitored Anesthesia Care vs. General Anesthesia for Transcatheter Aortic Valve Replacement

Medical University of South Carolina (MUSC)

Status: Completed

Conditions: Transcatheter Aortic Valve Replacement

Treatments: Procedure: General Endotracheal Anesthesia; Procedure: Monitored anesthesia care

Study type: Interventional

Funder types: Other

Identifiers

NCT04107038

Pro00088473

Details and patient eligibility

About

This study is being done to evaluate the impact that monitored anesthetic care (MAC) versus general endotracheal anesthesia (GETA) has on hospital length of stay, rate of ICU admission, and procedural mortality for patients undergoing Transcatheter Aortic Valve Replacement (TAVR). Also, the investigators hope to determine if the use of Transesophageal Echocardiography (TEE) during GETA impacts device success. Adult patients undergoing transfemoral approach TAVR for aortic valve stenosis may be eligible candidates for this study.

Enrollment: 170 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Adult patients ≥ 18 years old
• Adult patients undergoing transfemoral approach TAVR for aortic valve stenosis
• Adult patients who are medically eligible to receive both anesthetics (GA and MAC)

Exclusion criteria

• Inability to speak English
• Body Mass Index (BMI) > 37 kg/m2
• History of difficult airway requiring fiberoptic intubation
• Inability to lie flat
• Women who are pregnant
• Patients who have contraindications to either anesthetic, such as an allergy or history of malignant hyperthermia, will also be excluded from the study.
• Inability or unwillingness of subject to give informed consent based on any reason
• Patients with any of the following absolute contraindications to TEE:
• Perforated Viscus
• Esophageal Stricture
• Esophageal Tumor
• Esophageal Perforation
• Esophageal Diverticulum
• Active upper GI Bleed

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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170 participants in 2 patient groups

General

Active Comparator group

Description:

Participants randomized to group A will receive general endotracheal anesthesia as their anesthetic procedure.

Treatment:

Procedure: General Endotracheal Anesthesia

Sedation

Active Comparator group

Description:

Participants randomized to group B will receive monitored anesthesia care as their anesthetic procedure.

Treatment:

Procedure: Monitored anesthesia care